MAUDE Adverse Event Report: ABBOTT VASCULAR HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING

Catalog Number	1005351H
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in an unspecified vessel.The whisper ls guide wire was advanced to the lesion and intravascular ultrasound (ivus) was performed.When the ivus was removed, resistance was noted with the guide wire and a portion of the guide wire separated.The separated portion was removed together with the distal end of the ivus catheter; therefore nothing was left in the patient.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Additional information received 11/25/2019 indicates that the procedure was to treat a heavily calcified lesion in the mildly tortuous distal left circumflex coronary artery.The portion of the guide wire that was separated is not specified.No additional information was provided.
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with other devices and/or the heavily calcified and mildly tortuous anatomy resulted in the reported difficulty to remove.Manipulation of the device resulted in the reported bent/corkscrew core and ultimately resulted in the reported/noted core and black polymer separations.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9338811
• Report Number: 2024168-2019-13714
• Device Sequence Number: 13940856
• Product Code: DQX
• UDI-Device Identifier: 08717648037740
• UDI-Public: 08717648037740
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 1005351H
• Device Lot Number: 8092571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IVUS